Is flu vaccine supply in jeopardy from Australia’s CSL Biotherapies?

The answer depends on who you listen to: the FDA or the EVP at CSL Biotherapies. According to the FDA Warning Letter issued on June 15, 2011, the issues are among the most significant as any we have seen in recent years following the company withdrawal of the vaccine after reports of seizures with use in children.

Any observer and student of FDA enforcement recognizes the serious combination of observations:

No documentation of adverse events

Lack of production and process controls

Inadequate investigations into batch or component failures

Failure to reject components that did not meet specifications

Inappropriate laboratory methods

The list is lengthy, significant, and serious.

And the Warning Letter is topped off with the universal conclusion that we have seen with McNeil, BMS, Ningbo Smart and others reported in this blog—“Your Quality Unit is not fulfilling its responsibilities.”

When the FDA doubts the Quality Unit—it doubts everything.

So what about the flu supply from one of the world’s largest flu vaccine manufacturers? Are they too big to fail? Will they be permitted to supply the U.S.?

For starters, the Warning Letter was issued within a record two and a half months of the inspection. Also, the FDA requested a meeting with the CEO and other senior management, which is the equivalent of saying, “We’re in this mess together.”

So, how does the EVP at CSL view their issues?

Mr. Jeff Davies, CSL’s EVP was interviewed on “PM with Mark Colvin” on June 22, 2011.